Regulatory Affairs for Medical Devices, Pharmaceuticals & Biologics
Timeline
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February 1, 2024Experience start
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May 31, 2024Experience end
Experience scope
Categories
Healthcare Market research Market expansion Product or service launch Law and policySkills
regulatory affairs marketing medical devices regulatory sciences pharmaceuticals research commercializationA global, experiential, research university is seeking projects for their Master of Science in Regulatory Affairs capstone course.
The Master of Science in Regulatory Affairs program is designed to both broaden and deepen the student’s understanding of current global compliance requirements and their practical application in the design, development, approval, and post marketing of products utilized within regulated industries.
The capstone course challenges students to exercise their ability to translate global regulatory requirements for globally regulated product commercialization into submission-ready documents and broadly applicable regulatory science solutions.
This is your opportunity to connect with students and faculty from a renowned institution in New England that consistently ranks among the top universities in the United States and is known for its focus on interdisciplinary education, extensive research output, and collaborative student culture.
Learners
Deliverables are negotiable, and will seek to align the needs of the students and the organization.
Some final project deliverables might include:
- A 10-15 minute presentation on key findings and recommendations
- A detailed report including their research, analysis, insights and recommendations
Project timeline
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February 1, 2024Experience start
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May 31, 2024Experience end
Project Examples
Requirements
Student teams will work with your organization to identify your needs and provide actionable recommendations, based on in-depth research and analysis.
Desired project topics include:
Strategic Regulatory Affairs
- Classification
- Combination Product Approvals
- Global Commercialization
Clinical Research
- Clinical Trial Design
- Clinical Operations
- Study Rationales
Regulatory Compliance
- Adverse event profiling
- REMS
- Post Market Surveillance
General Regulatory Affairs
- Regulatory Market Research
We invite you to share your projects for consideration. Please include an executive summary of the regulatory affairs problem or topic. Be sure to include a brief description of your organization and mission.
Timeline
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February 1, 2024Experience start
-
May 31, 2024Experience end